Behind the price on that medicine label is a federal watchdog that is already at work, in the name of the Patented Medicine Prices Review Board (PMPRB). As Canada’s independent regulator for patented drug prices, its job is to make sure manufacturers do not charge too much, and more.
What does the Patented Medicine Prices Review Board do?
The PMPRB was established in 1987 through amendments to the Patent Act. It is an independent, quasi-judicial federal body accountable to Parliament through the Minister of Health, with two core responsibilities:
Price oversight
The PMPRB reviews what manufacturers charge for patented medicines at the factory level, called the “ex-factory” or “factory gate” price. If a formal hearing finds a price to be excessive, the Board can order price reductions or require repayment of excess revenues to the federal Crown.
However, the PMPRB has no authority over two things:
- what wholesalers, retailers, or pharmacies charge
- regulation over pharmacists’ professional fees
Market reporting
The PMPRB publishes annual reports on pharmaceutical pricing trends, sales figures, and the research-and-development spending of drug manufacturers across Canada.
Who leads the Patented Medicine Prices Review Board
Headquartered in Ottawa, the Board has up to five part-time members appointed by the Governor-in-Council. Currently, Board’s Chairperson is Anie Perrault.
More about PMPRB’s price review with this video:
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How long does a patent on medicine last?
As set out in the Patent Act, a standard Canadian patent runs for 20 years from the filing date. For pharmaceutical companies, however, that clock starts ticking long before a drug ever reaches a pharmacy shelf. Research, clinical trials, and obtaining Health Canada regulatory approval all consume years of that window.
To help compensate for this lost period, eligible manufacturers can apply for a Certificate of Supplementary Protection (CSP), a patent-like protection introduced through the Canada–EU Comprehensive Economic and Trade Agreement (CETA) Implementation Act.
As changes in the PMPRB regulatory framework came into force June 30, 2021, CSPs expanded the PMPRB’s jurisdiction to include these certificate holders, who must report their pricing information to the Board on the same terms as standard patentees.
What happens when a patent expires
Once a patent (and any CSP) expires, the PMPRB loses authority over that medicine’s price.
This was confirmed by the Federal Court of Appeal in Galderma Canada Inc. v. Canada (Attorney General), 2024 FCA 208. It ruled that the Board had overstepped when it required Galderma to produce pricing information for Differin (0.1% adapalene) after its patent expired in 2009.
The Court stated the PMPRB is not the “Patented and Unpatented Medicine Prices Review Board” nor the “All Medicine Prices Review Board.” As such, a medicine can be sold at market prices once a patent runs out.
In this video, the PMPRB’s Executive Director discusses the Board’s new guidelines and other recent changes:
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How does the PMPRB decide if a price is excessive?
The PMPRB does not publish approved drug prices and does not pre-authorize what manufacturers charge. Notably, the Patent Act does not define what an “excessive” price is. That determination can only be made by a Hearing Panel in the context of a specific public hearing.
The process is guided by the 2026 Guidelines for PMPRB Staff, which took effect January 1, 2026. These guidelines are directed at Staff, not at manufacturers. Until a Hearing Panel orders otherwise, manufacturers may set their own prices freely.
Initial and annual reviews
All patented medicines sold in Canada go through a first screen. Staff compares the Canadian list price against the Highest International Price (HIP), which is the highest price for the same medicine in any of the PMPRB11 comparator countries.
Staff also monitors year-over-year list price changes against Canada’s Consumer Price Index (CPI). A price increase that exceeds the CPI in any given year can flag a medicine for deeper review.
In-Depth Reviews and hearings
If a medicine raises a concern, it moves to an In-Depth Review, typically lasting 12 to 28 months. Staff examines all factors set out in section 85(1) of the Patent Act, including:
- the medicine’s Canadian list price
- prices of similar medicines in the same therapeutic class in Canada
- how the Canadian price compares to the PMPRB11 countries
- changes in the CPI over the review period
If Staff recommends a formal hearing, a Hearing Panel of at least two Board members makes the final determination.
When the federal government proposed sweeping new pricing factors in 2019, including pharmacoeconomic value and market size, the proposed changes faced legal challenges. Before the courts could rule on their validity, the Governor in Council withdrew those factors.
In Innovative Medicines Canada v. Canada (Attorney General), 2022 FCA 210, the court ultimately dismissed the industry challenge and upheld the government’s decision to change the comparator country basket to the PMPRB11, finding it a reasonable exercise of the regulation-making power under subsection 101(1) of the Patent Act. What took effect July 1, 2022 was the PMPRB11 country list and reduced reporting requirements for lower-risk medicines.
Daphne Lainson, a partner at Smart & Biggar LLP, put the practical effect plainly of how intellectual property lawyers are guiding clients through the drug pricing framework transition. The reforms, she noted, would “generally lower the price of a patented medicine in Canada,” with implications she described as potentially significant for market access decisions.
Can Canadians complain about high drug prices?
Although Canadian can complain about high drug prices, it cannot be done directly to the PMPRB. The Board’s complaint process is reserved for a defined group of approved bodies only:
- the federal Minister of Health
- provincial and territorial Ministers of Health, or their equivalents
- senior officials authorized to represent publicly-funded drug programs
A complaint from any of these approved parties automatically triggers an In-Depth Review, provided the medicine falls under PMPRB jurisdiction. Members of the public with concerns are encouraged to raise them with their provincial Minister of Health or their publicly-funded drug plan, which can choose to file a complaint on their behalf.
Drug pricing in Canada is also shaped by negotiations outside the PMPRB entirely. The pan-Canadian Pharmaceutical Alliance (pCPA), a collaboration among provincial and territorial drug plans, negotiates prices with manufacturers for publicly-funded formularies. The intersection of PMPRB directions and pCPA negotiations have become an increasingly layered space for counsel to navigate. Notably, drug pricing now sits at the centre of competing domestic and international forces for pharmaceutical legal teams.
Jill Daley, vice president of corporate affairs and general counsel at Eli Lilly Canada, described the scale of that pressure. The pharmaceutical industry, she said, “has been of interest to our government and governments around the world,” a reality that has grown more complicated with US Most-Favoured-Nation pricing signals adding cross-border pressure on how patented medicines are priced and accessed in Canada.
Patented Medicine Prices Review Board: the price check that never stops
As Canada’s drug price watchdog, the PMPRB has adapted to court rulings, shifting regulations, and a changing global pharmaceutical market. Understanding how the Board works is the first step to knowing your rights as a patient, and your options if those rights need enforcing.
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